Newsletter - July 22, 2021
FDA’s Decision-Making Process is Immune to Buyer’s Remorse
Once FDA has approved a product, it almost never reverses that decision unless there are compelling safety reasons such as previously unknown life-threatening events related to the drug. FDA vigorously defends its decisions and never expresses “buyer’s remorse”. A recent case emphasized this policy when FDA...Read More
FDA Would Like Inclusion of Pregnant Women in Clinical Research: Easier Said Than Done
Pregnant women are almost always excluded from clinical trials and pregnancy is usually considered an adverse event leading to dropping women from ongoing clinical trials. FDA, along with European regulators, would like to change that. But it is not easy to implement. There is no law that could mandate inclusion of...Read More
FDA’s Decision-Making Process is Immune to Buyer’s Remorse
Once FDA has approved a product, it almost never reverses that decision unless there are compelling safety reasons such as previously unknown life-threatening events related to the drug. FDA vigorously defends its decisions and never expresses “buyer’s remorse”. A recent case emphasized this policy when FDA...Read More
FDA Would Like Inclusion of Pregnant Women in Clinical Research: Easier Said Than Done
Pregnant women are almost always excluded from clinical trials and pregnancy is usually considered an adverse event leading to dropping women from ongoing clinical trials. FDA, along with European regulators, would like to change that. But it is not easy to implement. There is no law that could mandate inclusion of...Read More
